NurExone Demonstrates Scalable Exosome Production, Supporting Its Modular Manufacturing Strategy and Commercial Growth
TORONTO and HAIFA, Israel, Oct. 22, 2026 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical company developing exosome-based regenerative therapies for central nervous system injuries, today announced that it doubled exosome production by successfully operating two bioreactors in parallel, while maintaining the same overall production time, process consistency and comparable exosome quality. The achievement marks an important step in NurExone’s strategy to build scalable exosome manufacturing capabilities through its wholly owned U.S. subsidiary, Exo-Top Inc. (“Exo-Top”), and its manufacturing collaboration with Made Scientific.
NurExone is pursuing a modular approach that enables manufacturing capacity to expand by adding standardized production units in parallel (scaling out approach), rather than engineering larger bioreactor vessels (scaling up approach). This strategy has the potential to protect capital investments, accelerate development timelines, and allow production to match commercial demand, subject to successful validation and implementation.
“Our goal is to make increasing exosome production straightforward and robust,” said Dr. Tali Kizhner, Director of Research and Development at NurExone. “We have invested hundreds of hours in studying and optimizing our manufacturing process. This run shows that we successfully replicated that process to increase output while ensuring manufacturing of high-quality product, with similar characteristics and critical quality attributes (CQAs). The achieved milestone provides us a strong foundation for expanding production capabilities even further.”
Table 1: Comparative Quality and Potency Metrics Across Production Runs
| Product characteristic | Single Run A | Single Run B | Parallel Run (Two bioreactors) | |||
| Particle size (nm) | 140–145 | 130–145 | 135–140 | |||
| Surface electrical charge (mV) | −44.75 | −45.6 | −49.8 | |||
| Identity markers (CD9, CD63, CD81, TSG101) | Detected | Detected | Detected | |||
| Purity (Protein impurities removed) | >95% | >95% | >95% | |||
| Anti-inflammatory activityi | <10⁹ | <10⁹ | <10⁹ | |||
| Relative Exosome Yield (above 1013 exosomes per single bioreactor) | 100% | 100% | 200% | |||
As shown in Table 1, the exosomes produced in the parallel run retained comparable physical characteristics, the same identifying proteins and anti-inflammatory activity, providing initial evidence that greater output can be achieved while maintaining consistency.
“Scalable manufacturing is critical in positioning NurExone as a leader in this rapidly evolving exosome-based field. Demonstrating that two bioreactors can operate in parallel to double yield while maintaining process consistency strengthens our ability to respond to future demand and achieve market leadership,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “Through Exo-Top and our U.S. manufacturing collaborations, we are building the high-efficiency capabilities required to support both our internal therapeutic pipeline and potential business-to-business commercial opportunities for naïve exosomes.”
Supporting Therapeutic Development and Commercial Opportunities
NurExone is pursuing a dual-track strategy that combines the development of regulated exosome-based therapies with commercial opportunities for naïve mesenchymal stromal cell-derived exosomes through Exo-Top.
Its lead therapeutic candidate, ExoPTEN, is being developed for acute spinal cord injury and optic nerve damage. In parallel, Exo-Top is advancing manufacturing and commercial collaborations involving naïve exosomes for potential applications beyond the Company’s drug development pipeline.
About NurExone
NurExone is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve damage. Regulatory milestones, including obtaining the Orphan Drug Designation from the U.S. FDA and European EMA, facilitate the Company’s roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company aims to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, X (formerly Twitter), Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: 212-845-4200
Email: nurexone@russopartnersllc.com
Dr. Eva Reuter
Investor Relations - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements are based on expectations, estimates and projections as of the date of this press release and are generally identifiable by words such as “may,” “will,” “could,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “continue,” “advance” and similar expressions.
Forward-looking statements in this press release include statements concerning: the potential scalability, repeatability and consistency of the Company’s modular exosome manufacturing approach; the potential to expand manufacturing capacity by operating additional standardized production units in parallel; the potential technical, timing, capital and risk-management benefits of that approach; the Company’s plans to validate, develop and expand its manufacturing capabilities through Exo-Top and with third-party collaborators, including Made Scientific; the ability of the Company’s manufacturing capabilities to support its internal therapeutic pipeline and potential business-to-business supply opportunities; future demand for naïve exosomes; the continued development of ExoPTEN for acute spinal cord injury and optic nerve damage; and the Company’s broader development, regulatory, clinical and commercialization plans for exosome-based therapies, exosome products and targeted delivery systems.
These forward-looking statements are based on material assumptions including that: the reported production-run data and the Company’s interpretation of those data are accurate and complete; the parallel production results can be reproduced in additional runs and at greater scale; the selected analytical results are appropriate indicators of product comparability; the Company will be able to validate its processes and meet applicable quality, regulatory and manufacturing standards; additional bioreactors, facilities, materials, personnel, funding and collaborators will be available on acceptable terms; arrangements with Made Scientific and other counterparties will progress as contemplated; demand for naïve exosomes and related services will develop; and the Company will be able to advance ExoPTEN and its other programs as currently contemplated.
Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially, including: the preliminary and limited nature of the reported production results; the risk that the results will not be reproduced in additional runs or at larger scale; variability inherent in biological manufacturing; the risk that parallel production will not result in consistent quality attributes, regulatory acceptance, lower costs, shorter timelines or reduced operational risk; equipment, contamination, process-failure, supply-chain, facility, personnel and quality-control risks; the need for further process development, validation and technology transfer; the inability to secure sufficient financing, materials, personnel, facilities or collaborators; delays, changes or termination affecting arrangements with Made Scientific or other counterparties; the absence of commercial orders or sufficient market demand; competition and technological change; regulatory, clinical-development, intellectual-property and commercialization risks; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s annual information form dated August 27, 2024 and other continuous disclosure documents available under the Company’s SEDAR+ profile, copies of which are available under the Company’s SEDAR+ profile at www.sedarplus.ca.
The production results described in this press release do not establish commercial-scale manufacturing capability or regulatory compliance and should not be interpreted as demonstrating that the Company can manufacture products consistently at commercial scale. ExoPTEN is an investigational product candidate, has not been approved for commercial use or for the treatment of any condition by any regulatory authority, and its safety and efficacy in humans have not been established. Although the Company believes that the expectations and assumptions reflected in the forward-looking statements are reasonable, there can be no assurance that the anticipated activities, benefits, demand or results will occur or be achieved. Readers should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of this press release, and the Company disclaims any obligation to update or revise them except as required by applicable law.
Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
i Particle concentration (particles/mL) needed to reduce IL-6, an inflammatory signaling protein, by 50%. Lower concentrations indicate greater potency. The results are reported as thresholds, not exact values.
